Type 1 Diabetes Telemedicine

NCT ID: NCT03374462

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2019-10-31

Brief Summary

At the conclusion of this project, investigators will have assessed the effectiveness of home-based telemedicine for improving multiple important clinical and patient-centered outcomes in a high-risk pediatric cohort with T1D.

Aim 1. To test the hypothesis that home-based telemedicine is a feasible and acceptable method of care delivery for patients with poorly controlled type 1 diabetes (T1D) currently cared for at the University of California, Davis (UCD) Pediatric Endocrinology clinic. Specifically:

A) Patients and families choose to participate in telemedicine visits as a supplement to in-person care; B) Patients and families can utilize secure, internet-based platforms to upload and share glucose meter data and to establish an audio-video connection with a diabetes specialist in their home settings; C) Patients and families are satisfied with the experience of home-based telemedicine and would choose to receive future diabetes care via this modality.

Aim 2. To test the hypothesis that using home-based telemedicine, these patients can complete more frequent visits with a diabetes specialist than they previously completed via office visits alone.

Aim 3. To test the hypothesis that increased contact with a diabetes specialist via home-based telemedicine will lead to significant improvement in glycemic control for these patients.

Aim 4. To evaluate the effects of increased contact with a diabetes specialist via home-based telemedicine on high-cost health care utilization - specifically emergency department (ED) visits and diabetes-related hospitalizations.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telemedicine Intervention

All participants will receive the study intervention, which consists of home-based telemedicine visits with a diabetes specialist, at a frequency determined by the patient's degree of glycemic control (every 4, 6, or 8 weeks).

Group Type: EXPERIMENTAL

Telemedicine Intervention

Intervention Type: BEHAVIORAL

Home-based telemedicine visits

Interventions

Telemedicine Intervention

Home-based telemedicine visits

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 1-17 years
• known diagnosis of T1D
• >1 prior visit to the UC Davis Pediatric Endocrinology clinic (to avoid enrolling newly diagnosed patients)
• suboptimal glycemic control, defined as most recent hemoglobin A1C level of >8%
• access to the internet via a device with video and audio capability (e.g. computer, tablet, mobile phone)
• ability to connect their home glucose meter to an internet-capable device via Bluetooth or physical cable for the purpose of data uploading.

Exclusion Criteria

• Patients and parents whose primary language is not English
• Patients who have Western Health Advantage health insurance

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Crossen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California-Davis

Sacramento, California, United States

Countries

United States

Other Identifiers

1125857

Identifier Type: -

Identifier Source: org_study_id